Impact in the Medical Care Among the Rheumatic Diseases Patients in a Hospital in México During COVID-19 Pandemic

NCT ID: NCT04557358

Last Updated: 2022-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

670 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-05-31

Brief Summary

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The National Institute of Medical Sciences and Nutrition is a national reference center for rheumatic diseases that belongs to The National Institutes of Health, and has Federal founding. More than 8,000 patients with a wide variety of rheumatologic diagnosis receive medical care.

On March 2020, the WHO announced COVID-19 outbreak a pandemic. The first case was registered in Mexico on February 2020. In March 2020, the Mexican Government requested that our Institution should restrict health care to exclusively COVID-19 patients; accordingly, outpatient consultations were, and up to August 2020 still, hold on.

Meanwhile, when possible, the Department of Immunology and Rheumatology has implemented an "on-demand", non-organized patient´s health care, through email and phone contact; nonetheless, and due to the middle-low socioeconomic status of most of our patients and limited technical resources available at our Institution, the attempt has been challenging.

Detailed Description

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The aim objective of this project is to explore patients perception about access to medical care and to medications, access to communication with their primary rheumatologist and patients risk perception about COVID-19 disease, for this a survey directed (questionnaire locally developed) will apply and to explore how the reintegration at the usual medical care has a positive impact in the patient´s disease activity, patient´s quality of life and psychopathology (depression, anxiety and posttraumatic stress).

Conditions

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Rheumatoid Arthritis Quality of Life

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Rheumatic diseases outpatients

All the rheumatic diseases outpatients from the National Institute of Medical Sciences and Nutrition that will assist their usual medical care posterior of stopped it during the COVID-19 pandemic.

In order to explore how the patient´s disease activity, patient´s quality of life, and psychopathology will change with the reintegration at medical care, randomization 200 rheumatic diseases outpatients that will respond RAPID-3 (disease activity/disease severity), WHOQOL-BREF instrument (quality of life), DASS-21 instrument (depression and anxiety), IER-R (posttraumatic stress)

COVID-19 survey

Intervention Type OTHER

A questionnaire locally developed to explore access to medical care and to medications, access to communication with their primary rheumatologist, and patients risk perception about COVID-19 disease

RAPID-3

Intervention Type OTHER

The instrument measures function, pain, and patient global estimate of status, with correspond to activity disease

WHOQOL-BREF

Intervention Type OTHER

The instrument measures the patient´s quality of life (4 dimensions: physics, phycological, social, and environment)

DASS-21 instrument (depression and anxiety)

Intervention Type OTHER

The instrument measures the presence of depression and anxiety

IER-R (posttraumatic stress)

Intervention Type OTHER

The instrument measures the presence of posttraumatic stress

Interventions

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COVID-19 survey

A questionnaire locally developed to explore access to medical care and to medications, access to communication with their primary rheumatologist, and patients risk perception about COVID-19 disease

Intervention Type OTHER

RAPID-3

The instrument measures function, pain, and patient global estimate of status, with correspond to activity disease

Intervention Type OTHER

WHOQOL-BREF

The instrument measures the patient´s quality of life (4 dimensions: physics, phycological, social, and environment)

Intervention Type OTHER

DASS-21 instrument (depression and anxiety)

The instrument measures the presence of depression and anxiety

Intervention Type OTHER

IER-R (posttraumatic stress)

The instrument measures the presence of posttraumatic stress

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with a rheumatic disease diagnosis according to their primary rheumatologist who agree to participate

Exclusion Criteria

* Patients with a not confirmed rheumatic disease
* Patients lost to follow-up from the outpatient for \> 1 year period
* Patients with pregnancy plans
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Medical Sciences and Nutrition, Salvador Zubiran

OTHER

Sponsor Role lead

Responsible Party

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Virginia Pascual Ramos

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Virginia Pascual-Ramos, Dr.

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Locations

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Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, Tlalpan, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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IRE-3467

Identifier Type: -

Identifier Source: org_study_id

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